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Titan Implants I10C-4.2, 16

by A.B. Dental Devices Ltd

Titan Implants I10C-4.2, 16 (I10C-4.2,16) is a Class II device made by A.B. Dental Devices Ltd, cleared under FDA 510(k) K250806 on 18 Jun 2026 and listed in FDA GUDID since 16 Aug 2026 (UDI-DI 07290111270956), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K250806

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290111270956 UDI-DI Date16 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250806 Date18 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250806 decided 18 Jun 2026 Active
  • FDA GUDID UDI-DI 07290111270956 listed 16 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250806
  2. Listed FDA GUDID 07290111270956

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Titan Implants
Generic name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
I10C-4.2, 16
Primary DI / UDI-DI
07290111270956
510(k) Number
FDA product code
DZE
GMDN term
Screw endosteal dental implant, two-piece
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K250806)

and 8 more cleared under K250806

Similar devices

Other devices filed under FDA product code DZE (Implant, Endosseous, Root-Form).

Other devices from A.B. Dental Devices Ltd

See all devices from A.B. Dental Devices Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)